Phase 2
N=59
Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor
Gastric Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00711243 ↗Enrolled (actual)
59
Serious AEs
24.1%
Results posted
Oct 2018
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I) — 50 mg/m2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- docetaxel (Drug); fluorouracil (Drug); oxaliplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I) |
50 | — |
| PRIMARY Response Rate in Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (Phase II) |
73.2 | — |
| SECONDARY Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Frequency of CYP3A4, CYP3A5, and MDR Polymorphisms and Their Impact on Docetaxel Toxicity |
— | — |
| SECONDARY Frequency of XRCC1 and ERCC2 Polymorphisms and Their Impact on Oxaliplatin Toxicity |
— | — |
| SECONDARY Frequency of DPD and TSER Polymorphisms and Their Impact on Fluorouracil Toxicity |
— | — |
| SECONDARY Toxicity Profile |
23; 31; 15; 30; 13; 36 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic or surgically unresectable solid tumor meeting 1 of the following criteria:
- Any solid tumor (Phase I)
- Adenocarcinoma of the stomach or gastroesophageal junction (Phase II)
- Unidimensionally measurable disease by CT scan or MRI
- No uncontrolled brain metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin normal
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times ULN
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
- No preexisting neuropathy
- No concurrent uncontrolled illness or other condition that would preclude study compliance
- No history of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 4 weeks since prior therapy (Phase I)
- No prior oxaliplatin or taxanes (Phase I)
- More than 4 weeks since prior radiotherapy (Phase I)
- No more than two prior therapies for metastatic disease (Phase I)
- No prior therapy for metastatic disease (Phase II)
- At least 6 months since prior adjuvant therapy (given prior to the occurrence of metastatic disease) (Phase II)
- Prior fluorouracil and concurrent radiotherapy for palliation of the primary tumor allowed provided metastatic disease is present outside the radiotherapy field (Phase II)
- No prior radiotherapy to ≥ 30% of bone marrow
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00711243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.